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临床试验/NCT07238088
NCT07238088招募中不适用

Monitoreo Activo de Mamografía y Orientación

University of Puerto Rico Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 1,020 人开始时间: 2026年1月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,020
试验地点
1
主要终点
Number of participants who self-reported having had a mammogram

研究概览

简要总结

The Puerto Rico Community Engagement Alliance (PR-CEAL) is an NIH-funded initiative which aims to improve health literacy and healthcare access across Puerto Rico. In 2024, the program developed a new study which goal is to improve breast cancer screening rates in Puerto Rico titled Monitoreo Activo de Mamografía y Orientación (MAMO). This multi-level study will recruit non-adherent women based on residence, age (40 to 74 years old), and having had two or more years since their last breast cancer screening. The intervention will focus on 39 municipalities with screening rates below the median, through three different levels: educational, navigation, and integration.

At the educational level, the intervention will employ a community-based recruitment strategy led by Community Health Workers (CHWs), who will identify eligible women at community venues and conduct follow-up via telephone to provide educational support. Drawing on findings from a previous pilot study and addressing barriers specific to non- adherent women, the navigation-level intervention will incorporate the role of a Community Navigator to deliver tailored support and facilitate breast cancer screening uptake through collaboration with local networks and partnerships. The integration-level intervention will build upon the educational and navigation components by enhancing knowledge, attitudes, skills, and organizational processes within Federally Qualified Health Clinics (FQHCs). This component is designed to foster a supportive healthcare environment that encourages routine mammography screening. The integration-level intervention will be implemented in four FQHCs across PR.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Screening
盲法
None

入排标准

年龄范围
40 Years 至 74 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women (biological sex at birth) aged 40- 74
  • Residing in one of 39 municipalities across Puerto Rico whose having a low breast cancer screening rate below the median (38.6%): Aibonito, Arecibo, Barceloneta, Caguas, Camuy, Comerío, Corozal, Florida, Las Piedras, Loíza, Naguabo, Vieques, Villalba, Añasco, Carolina, Cayey, Dorado, Guayanilla, Guaynabo, Isabela, Juana Diaz, Juncos, Luquillo, Manatí, Peñuelas, Quebradillas, Cabo Rojo, Canóvanas, Ceiba, Ciales, Coamo, Culebra, Fajardo, Morovis, Ponce, Sabana Grande, San Juan, Santa Isabel, and Trujillo Alto.
  • Overdue for breast cancer screening by one or more years, in accordance with annual guidelines
  • Adequate cognitive orientation as verified by a brief version of the Mini-Mental State Examination
  • Access to a telephone for follow-up and communication
  • Ability to read and comprehend Spanish to engage with educational materials.

排除标准

  • Women outside the specified age range (40-74)
  • Up to date in breast cancer screening according to the annual recommendations.
  • No cognitive orientation
  • Participants without access to a telephone
  • Unable to read and comprehend Spanish
  • Women undergoing active cancer treatment
  • History of radical mastectomy

研究组 & 干预措施

Educational Level

Experimental

Individual educational component

干预措施: Individual Education (Behavioral)

Navigation Level

Experimental

干预措施: Individual Education (Behavioral)

Navigation Level

Experimental

干预措施: Community Navigation (Other)

Integration level

Experimental

干预措施: Individual Education (Behavioral)

Integration level

Experimental

干预措施: Community Navigation (Other)

Integration level

Experimental

干预措施: Healthcare Providers Educational Intervention (Other)

结局指标

主要结局

Number of participants who self-reported having had a mammogram

时间窗: Up to 6 months

Participants will receive follow-up calls and emails every 3 months for 6-months to document their efforts to attend the clinic, undergo a mammogram, and receive a progress report from the clinicians about their mammogram result. The categories to collect this information are: Yes/No/Refuse to Answer.

Number of participants who self-reported having had a mammogram

时间窗: Up to 12 months

Participants will receive follow-up calls and emails every 3 months for one year to document their efforts to attend the clinic, undergo a mammogram, and receive a progress report from the clinicians about their mammogram result. The categories to collect this information are: Yes/No/Refuse to Answer.

次要结局

  • Changes in the mammogram rates considering intervention level: the Educational, Navigation, and Integration Levels(Up to 6 months)
  • Changes in the mammogram rates considering intervention level: the Educational, Navigation, and Integration Levels(Up to 12 months)

研究者

发起方
University of Puerto Rico Comprehensive Cancer Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vivian Colon Lopez

Investigator Lead & Associate Director

University of Puerto Rico Comprehensive Cancer Center

研究点 (1)

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